Test Definitions (LIMS)

A test definition defines which test definition steps, test definition result records, and lab input records (such as instruments or consumables) LIMS needs to generate when a Test is created. The result definitions and inputs are defined on steps and reflect what the test definition procedure requires to be captured during test execution.

Test Definition Version Control

Test Definition records are subject to Vault LIMS version control. Once these records are Approved, they become locked and cannot be edited. Instead, you must create a new version using the Create New Version action on the record.

When a test definition is created, Vault automatically creates an associated LIMS Change Analysis record in the background. As part of the Change Analysis process, records referenced by the new version of the Test Definition (e.g., another Test Definition record, Spec Data records) will also have a new version created (managed by the Change Analysis).

Creating Test Definitions

To create a Test Definition record:

1. Navigate to Business Admin > Test Definitions, or to a custom object tab.
2. Click Create.
3. Enter a Name.
4. Optional: Enter an Estimated Duration.
5. Optional: Select a Method Document. This determines which document is shown side-by-side with the lab results grid on the test execution page. You are selecting a document and not a specific document version in this step, but Vault selects the latest steady-state version of this document during test execution.
6. Click Save.

Adding Test Definition Steps to your Test Definition

Each Test Definition contains one or more Test Definition Steps. At test execution, steps will contain one (1) or more inputs or results and they typically correlate to one (1) or more steps within the method document.

To create a Test Definition Step:

1. Navigate to the Test Steps section of a Test Definition record.
2. Click Create.
3. Enter a Name.
4. Enter an Order. This determines the order the step will be presented within the test execution page.
5. Click Save.

Repeat for additional Test Definition Steps.

Adding Test Definition Results to your Test Definition

Each Test Definition contains one or more Test Definition Results, which Lab Results are created from at runtime. Test Definition Results contain many attributes that determine how the Lab Result will be displayed, how the data will be entered, what values it will accept, and even how the values will be formatted for the lab analyst in the test execution page.

To create a Test Definition Result:

1. Navigate to the Result Definitions section of a Test Definition record.
2. Click Create.
3. Select a result type from the drop-down. The result types available are:
   • Numeric (includes the option to define a calculation)
   • Picklist
   • Date
   • Date Time
   • Text
4. Enter a Name. This is how the Lab Result label will appear in the test execution grid.
5. Select a Test Definition Step. If only one (1) Test Definition Step exists, it will be defaulted.
6. Enter an Order. This determines the Test Definition Step’s positioning among the other results in the test execution grid.
7. Select a Data Entry Method:
   • Manual: Allows the user to input the value during test execution.
   • Integration: The value is drawn from data via Vault integrations.
   • Calculation: The value is the result of a predefined calculation. This entry method is only available for the Numeric Result definition type.
8. Select the Required? Yes/No field to define if a value must be populated during test execution.
9. For a Numeric Result, populate the following fields as applicable:
   • Unit of Measure
   • Notation (standard or scientific eNotation)
   • Rounding Rule (USP orASTM)
   • Precision Type (Decimal Places or Significant Figures)
   • Precision: Enter a numeric value. This is to format the result for display purposes during test execution. For whole numbers, the Precision value should be 0.
10. For a Picklist Result you must select a Lab Result Picklist record from the drop-down, which determines the picklist from which the lab Analyst will select a picklist value during test execution. This is a LIMS object, not the platform Picklist component.
11. Click Save.

Add Test Definition Inputs to your Test Definition

In addition to Test Definition Results, you can also define the Test Definition Inputs that should be captured during test execution. These include specific instruments (assets) and consumables that should be used in the test.

To create a Test Definition Input:

1. Navigate to the Inputs (Assets and Consumable) section of a Test Definition record.
2. Click Create.
3. Select an input type from the drop-down. The input types available are:
   • Consumable
   • Instrument
4. Enter a Name.
5. Select a Test Definition Step. If only one (1) Test Definition Step exists, it will be defaulted.
6. Enter an Order. This determines the Test Definition Step’s positioning among the other results in the test execution grid.
7. Select a Consumable Family or Instrument Family. During test execution, the inputs available for selection will be limited to records having the same family value.
8. Select the Required? Yes/No field to define if a value must be populated during test execution.
9. For Consumable input types, optionally populate the Expected Amount and Expected Amount Unit fields. These values will be displayed to the lab analyst during test execution where they can record the actual amount used.

Add Variations to your Test Definition

In some cases, it may be necessary for laboratory tests to include multiple variations for things such as differences in analysis approach, product makeup, or units. In Vault LIMS, you can add Variations to a Test Definition to capture these needs. Creating a Test Definition Variation is optional. However, if a Test Definition has one or more Variations, runtime tests can only be created from a Variation and not the base Test Definition.

To add a variation to your Test Definition:

1. Navigate to your Test Definition record and set the Has Variations? field to Yes.
2. In the Lab Test Definition Variations section, click Create.
3. Enter a Name.
4. Optional: Enter a Description of the Variation.
5. Click Save.

From your newly created Lab Test Definition Variation record, you can add Lab Test Definition Variation Inputs or Lab Test Definition Variation Results as needed based on the Test Definition Inputs and Test Definition Results that exist in the Test Definition record.

To create a Lab Test Definition Variation Input:

1. In the Actions menu, select Create Variation Inputs.
2. In the following dialog, select one or more Test Definition Input records. The records displayed are the Test Definition Inputs in the Test Definition for which a corresponding Test Definition Variation Input record has not been created.
3. Click OK.

The system creates a Test Definition Variation Input record for each Test Definition Input selected. If any values need to be modified (for example, Required, Expected Amount, or Expected Amount Units), you can make the necessary changes on the applicable Test Definition Variation Input record.

To add more Test Definition Variation Input records, repeat the steps above as needed.

To create a Lab Test Definition Variation Result:

1. From the Actions menu, select Create Variation Results.
2. In the following dialog, select one or more Test Definition Result records. The records displayed are the Test Definition Results in the Test Definition for which a corresponding Test Definition Variation Result record has not been created.
3. Click OK.

The system creates a Test Definition Variation Result record for each Test Definition Result selected. If any values need to be modified (for example, Required, Precision, Precision Type, or Unit of Measure), you can make the necessary changes on the applicable Test Definition Variation Result record.

To add more Test Definition Variation Result records, repeat the steps above as needed.

About Lab Result Picklists

Unlike standard Vault picklists, Lab Result Picklists are object records, populated with related Lab Result Picklist Option records.This allows you to define what picklist options are available to the user for this specific result when they’re executing a Lab Test.